Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901884699124 Date of Approval: 14/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF CORE STABILITY AND TREADMILL TRAINING ON BALANCE IN DOWN SYNDROME CHILDREN
Official scientific title EFFECT OF CORE STABILITY AND TREADMILL TRAINING ON BALANCE IN DOWN SYNDROME CHILDREN
Brief summary describing the background and objectives of the trial Each of the core stability exercises and treadmill training play as a role of physical therapy interventions and has an effect on the balance in children with Down syndromes, and there is no study investigate if the core stability exercises or treadmill training has more effect on the improvement of the balance. The objective of this research is to investigate the effect of core stability training versus treadmill exercises on the balance in children with Down syndrome.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Genetic Diseases,Musculoskeletal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/01/2019
Actual trial start date 15/01/2019
Anticipated date of last follow up 15/03/2019
Actual Last follow-up date 15/03/2019
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional Physical therapy program 60 min within 60 minutes for balance and posture control including the following items with explicit instructions to the child to; the therapist sit behind the standing child with feet together while the therapist locked the child’s knees manually, then, slowly tilted the child forward, backward and sideway; therapist behind the step-standing child and guided to shift child’s weight forward and backward alternately; high step-standing child and try to keep balanced; child stood with locked knees manually by the therapist and child tried actively to stoop and recover; applied righting, equilibrium, and protective reactions training. 15 Active-Treatment of Control Group
Experimental Group Core stability exercises with traditional physical therapy program 60 min children received the same traditional physical therapy exercises of group A (within 30 minutes), in addition to core stability training. Jeffrey’s core stability exercises for eight weeks, and three thirty-minute sessions per week (every other day) . Based on Jeffrey’s protocol, the protocol included specific spinal stabilization exercises, lumbar-pelvic proprioception retraining, and abdominal maneuvers (holding the abdomen in) and multifidus muscle contraction, followed by maintaining stabilization maneuver using dynamic stability achieved in different positions (supine, prone, and squatting) and addition of dynamic elements (limb movement, use of Swiss ball) in later stages. 15
Experimental Group Treadmill training with traditional physical therapy program 60 min The child walked the treadmill (Motorized treadmill Make (EN-TRED, Enraf Nonius)) at 75% of over-ground speed and individually prescribed low- endurance walking at 0% incline21 for 20 min, three times weekly for eight successive weeks. The walking area of this treadmill is made of heavy steel of minimum 8-inch thickness and are available with cushioning to absorb impact load. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Down syndrome child age ranged from four to six years able to understand commands given to them, stand and walk independently with repeated falling neurological disorders musculoskeletal disorders mobility disorders cardiac anomalies, vision or hearing loss Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(s) 6 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 15/01/2019 Research Ethical Committe
Ethics Committee Address
Street address City Postal code Country
Zaqasic Zaqasic 11121 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional Balance 0.5
Secondary Outcome Overall Stability Index 0.5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Intensive Pediatrics Physical Therapy Center Zaqasic Zaqasic Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
our own study No fund received from grant Zaquazic Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Reham Saeed Alsakhawi The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University Cairo Egypt University
Primary Sponsor Mohamed Ali Elshafey The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham Saeed Alsakhawi Faculty of physical therapy Cairo university Egypt
Mohamed Ali Elshafey Faculty of physical therapy Cairo university Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elshafey elrahmapt@gmail.com 00201280232088 The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Reham Alsakhawi rsm211_pt@yahoo.com 00966504182628 The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elshafey elrahmapt@gmail.com 00201280232088 The Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information